UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, DC 20549
FORM
Current Report Pursuant
to Section 13 or 15(d) of the
Securities Exchange Act of 1934
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Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below):
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Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§ 230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§ 240.12b-2 of this chapter).
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If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
Item 2.02. Results of Operations and Financial Condition.
On August 7, 2023, Theravance Biopharma, Inc. issued a press release and is holding a conference call regarding its financial results for the quarter ended June 30, 2023 and a business update. A copy of the press release is furnished as Exhibit 99.1 to this Current Report and a copy of materials that will accompany the call is furnished as Exhibit 99.2 to this Current Report.
The information in Item 2.02 and in Item 9.01 of this Current Report on Form 8-K, including Exhibits 99.1 and 99.2, is being furnished and shall not be deemed “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Securities Exchange Act of 1934”), or otherwise subject to the liabilities of that Section, nor shall it be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, except as expressly set forth by specific reference in such a filing.
Item 9.01. Financial Statements and Exhibits.
(d) Exhibits.
| 99.1 | Press Release dated August 7, 2023 | |
| 99.2 | Slide deck entitled Second Quarter 2023 Financial Results and Business Update | |
| 104 | Cover Page Interactive Data File (cover page XBRL tags embedded within the Inline XBRL document) |
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
| THERAVANCE BIOPHARMA, INC. | ||
| Date: August 7, 2023 | By: |
/s/ Aziz Sawaf |
| Aziz Sawaf | ||
| Senior Vice President and Chief Financial Officer | ||
Exhibit 99.1
Theravance Biopharma, Inc. Reports Second Quarter 2023 Financial Results and Provides Business Update
| ● | Q2 2023 YUPELRI® (revefenacin) net sales of $55.0 million, recognized by Viatris, up 12% from Q2 20221 |
| ● | Q2 2023 YUPELRI total retail TRx and new to product TRx again reached all-time highs, up 26% and 53%, Y/Y, respectively2 |
| ● | PIFR-2 enrollment nearing completion; top-line data in late Q4 2023, with disclosure anticipated in January 2024 |
| ● | Company expects to complete $325 million capital return program by year-end, having returned $80.5 million via share repurchases during Q2 2023 and $263.8 million since inception through quarter end |
DUBLIN, IRELAND – aug 7, 2023 – Theravance Biopharma, Inc. (“Theravance Biopharma” or the “Company”) (NASDAQ: TBPH) today announced financial and operational results for the second quarter of 2023.
“We are very encouraged by our team’s performance in Q2, with YUPELRI achieving good growth in both the hospital and community settings over the prior year,” said Rick E Winningham, Chief Executive Officer. “We are excited to capitalize on the commercial opportunity for YUPELRI, potentially enhanced near-term by PIFR-2, and realize the significant opportunity for ampreloxetine to dramatically improve the lives of MSA patients with symptomatic nOH.”
Quarterly Highlights
| ● | YUPELRI® (revefenacin) inhalation solution, the first and only once-daily, nebulized bronchodilator approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). YUPELRI achieved $55.0 million Q2 2023 sales, increasing 12% year-over-year (Q2 2023 vs Q2 2022)1. YUPELRI’s share of the long-acting nebulized COPD market again reached all-time highs, with hospital share at 15.2% (vs. 11.6% in Q2 ’22) and community share at 29.0% (vs. 25.3% in Q2 ‘22)3. |
Theravance expects to complete enrollment in the YUPELRI PIFR-2 study shortly, with top-line data to be available late in the fourth quarter of 2023. The Company expects to disclose top line results in January 2024. PIFR-2 evaluates revefenacin delivered via jet nebulizer compared to tiotropium delivered via dry powder inhaler in severe to very severe COPD patients with suboptimal peak inspiratory flow rate.
| ● | Ampreloxetine, an investigational, once-daily norepinephrine reuptake inhibitor in development for the treatment of symptomatic neurogenic orthostatic hypotension (nOH) in patients with multiple system atrophy (MSA). During the second quarter, Theravance continued to focus on site activation and recruitment for the CYPRESS Phase 3 study. The team submitted a clinical trial application for multiple EU countries through the region’s centralized process, as well as in the UK and other countries around the world; key approvals are expected in the coming months. In addition, Theravance’s clinical team submitted abstracts to be presented at medical meetings during the second half of the year. |
1 In the US, Viatris is leading the commercialization of YUPELRI, and the Company co-promotes the product under a profit and loss sharing arrangement (65% to Viatris; 35% to the Company).
2 Symphony Health METYS Prescription Dashboard. Retail data serves as a proxy for the total community (Retail + DME).
3 Hospital LA-NEB Market Share - IQVIA DDD through 6/30/2023. Community LA-NEB Market Share includes Retail + DME / Med B FFS through May’23.
| Page 1 of 8 |
| ● | Financial Update: |
$80.5 million of share buybacks completed in Q2 2023 and $263.8 million from program inception through June 30, 2023. As of June 30, 2023, the Company had $61.2 million remaining in the program, which is expected to be completed by the end of 2023. The Company remains on track to achieve non-GAAP profitability in H2 ’23, subject to YUPELRI’s increased net sales growth4.
| ● | TRELEGY ELLIPTA (first once-daily single inhaler triple therapy for COPD and asthma) GSK posted second quarter 2023 global net sales of $760 million (up 29% from $591 million reported in the second quarter of 2022).5 Year to date, through the second quarter, GSK has posted TRELEGY global net sales of $1.3 billion. Theravance Biopharma is entitled to a milestone payment from Royalty Pharma of $50 million if TRELEGY global net sales are equal to or exceed $2.9 billion6 in 2023, the first of $250 million of potential milestones that can be achieved between 2023 and 2026. |
Second Quarter Financial Results
| ● | Revenue: Total revenue for the second quarter of 2023 was $13.7 million, consisting almost entirely of Viatris collaboration revenue. The Viatris collaboration revenue represents amounts receivable from Viatris and comprises the Company’s 35% share of net sales of YUPELRI, as well as its proportionate amount of the total shared costs incurred by the two companies. The non-shared YUPELRI costs incurred by Theravance Biopharma are recorded within operating expenses. While Viatris records the total net sales of YUPELRI within its financial statements, Theravance Biopharma’s implied 35% share of net sales of YUPELRI for the second quarter of 2023 was $19.3 million which represents a 12% increase compared to the same period in 2022. Viatris collaboration revenue increased by $2.9 million in the second quarter compared to the same period in 2022 due primarily to higher net sales. |
Total revenue for the second quarter represents a $2.7 million increase compared to the same period in 2022, primarily due to an increase in YUPELRI net sales.
| ● | Research and Development (R&D) Expenses: R&D expenses for the second quarter of 2023 were $9.4 million, compared to $14.9 million in the same period in 2022. Second quarter R&D expenses included total non-cash share-based compensation of $1.9 million. |
4 Non-GAAP profit (loss) consists of GAAP net income (loss) before taxes less share-based compensation expense and non-cash interest expense. See the section titled "Non-GAAP Financial Measures" for more information.
5 Source: GSK-reported Net Sales in USD.
6 The first milestone payment of $50.0 million will be triggered if Royalty Pharma receives $240.0 million or more in royalty payments from GSK with respect to 2023 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales reach approximately $2.863 billion. Royalties payable from GSK to Royalty Pharma are upward tiering from 6.5% to 10%.
| Page 2 of 8 |
| ● | Selling, General and Administrative (SG&A) Expenses: SG&A expenses for the second quarter of 2023 were $19.3 million, compared to $16.2 million in the same period in 2022. Second quarter SG&A expenses included total non-cash share-based compensation of $4.4 million. |
| ● | Stock Based Compensation: Share-based compensation expenses for the second quarter of 2023 were $6.3 million, compared to $9.7 million in the same period in 2022. Excluding restructuring-related expenses, share-based compensation expenses were $6.3 million and $7.9 million for the second quarter of 2023 and 2022, respectively. Share-based compensation expenses consisted of $1.9 million for R&D and $4.4 million for SG&A in the second quarter of 2023, compared to $2.9 million and $5.0 million, respectively, in the same period in 2022. The significant reduction in total share-based compensation expenses was primarily driven by our 2021 restructuring, which was substantially completed in early 2022 and our 2023 strategic actions, which was substantially completed by the end of March 2023. |
| ● | Restructuring and Related Expenses: Restructuring and related expenses for the second quarter of 2023 were $1.2 million compared to $3.0 million in the same period in 2022. The restructuring expenses in the second quarter of 2023 were classified as non-cash expenses and was related to the loss from the sale of lab equipment that generated net cash proceeds of $1.5 million. We do not expect any additional employee-related restructuring expenses, including share-based compensation expenses, related to the 2023 strategic actions. |
| ● | Net Loss from Operations and Non-GAAP Net Loss (from continuing operations)4 : Net loss from continuing operations was $15.6 million in the second quarter of 2023 compared to $22.8 million in the same period in 2022, and non-GAAP net loss from continuing operations was $7.4 million in the second quarter of 2023 compared to $13.1 million in the same period in 2022. Non-GAAP net loss from continuing operations consists of GAAP net income (loss) from operations, excluding share-based compensation expense, non-cash interest expense, and income tax expense (benefit). See the section titled "Non-GAAP Financial Measures" for more information. |
| ● | Cash Position: Cash, cash equivalents and marketable securities totaled $167.5 million as of June 30, 2023. |
2023 Financial Guidance
| ● | Operating Expenses (excluding share-based compensation and one-time restructuring costs): The Company continues to expect full year 2023 R&D expense of $35 million to $45 million and SG&A expense of $45 million to $55 million. |
| ● | The Company reaffirms its expectation that it will generate non-GAAP profit in 2H 2023, subject to YUPELRI’s increased net sales growth.4 |
| Page 3 of 8 |
Conference Call and Live Webcast Today at 5:00 pm ET
Theravance Biopharma will hold a conference call and live webcast accompanied by slides today at 5:00 pm ET / 2:00 pm PT / 10:00 pm IST. To participate in the live call by telephone, please register here. Those interested in listening to the conference call live via the internet may do so by visiting Theravance Biopharma’s website at www.theravance.com, under the Investors section, Presentations and Events.
A replay of the webcast will be available on Theravance Biopharma’s website for 30 days through September 6, 2023.
About the PIFR-2 Study
This study is a randomized, double-blind, parallel-group study, comparing improvements in lung function in adults with severe to very severe COPD and suboptimal inspiratory flow rate following once-daily treatment over 12 weeks with either YUPELRI (revefenacin) inhalation solution delivered via standard jet nebulizer or SPIRIVA® (tiotropium) delivered via a dry powder inhaler (Spiriva® HandiHaler®).
About Theravance Biopharma
Theravance Biopharma, Inc.’s focus is to deliver Medicines that Make a Difference® in people's lives. In pursuit of its purpose, Theravance Biopharma leverages decades of expertise, which has led to the development of FDA-approved YUPELRI® (revefenacin) inhalation solution indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD). Ampreloxetine, its late-stage investigational norepinephrine reuptake inhibitor in development for symptomatic neurogenic orthostatic hypotension, has the potential to be a first in class therapy effective in treating a constellation of cardinal symptoms in multiple system atrophy patients. The Company is committed to creating/driving shareholder value.
For more information, please visit www.theravance.com.
THERAVANCE BIOPHARMA®, THERAVANCE®, and the Cross/Star logo are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). YUPELRI® is a registered trademark of Mylan Specialty L.P., a Viatris company. Trademarks, trade names or service marks of other companies appearing on this press release are the property of their respective owners.
| Page 4 of 8 |
Forward-Looking Statements
This press release and the conference call will contain certain "forward-looking" statements as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma intends such forward-looking statements to be covered by the safe harbor provisions for forward-looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company’s repurchase of its ordinary shares by way of an open market share repurchase program, the impact of recent headcount reductions in connection with focusing investments in research, the Company’s governance policies and plans, the Company’s expectations regarding its allocation of resources and maintenance of expenditures, the Company’s goals, designs, strategies, plans and objectives, future YUPELRI sales, the ability to provide value to shareholders, the Company’s regulatory strategies and timing of clinical studies, possible safety, efficacy or differentiation of our investigational therapy, and contingent payments due to the Company from the sale of the Company’s TRELEGY ELLIPTA royalty interests to Royalty Pharma. These statements are based on the current estimates and assumptions of the management of Theravance Biopharma as of the date of this press release and the conference call and are subject to risks, uncertainties, changes in circumstances, assumptions and other factors that may cause the actual results of Theravance Biopharma to be materially different from those reflected in the forward-looking statements. Important factors that could cause actual results to differ materially from those indicated by such forward-looking statements include, among others, risks related to: whether the milestone thresholds can be achieved, delays or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non-clinical studies indicate the Company’s product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical studies, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture and commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporting infrastructure, ability to retain key personnel, the impact of the Company’s recent restructuring actions on its employees, partners and others, the ability of the Company to protect and to enforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company’s shares, and general economic and market conditions. Other risks affecting Theravance Biopharma are in the Company's Form 10-Q filed with the SEC on May 10, 2023, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma’s filings with the SEC, other unknown or unpredictable factors also could affect Theravance Biopharma’s results. No forward-looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place undue reliance on these forward-looking statements. Theravance Biopharma assumes no obligation to update its forward-looking statements on account of new information, future events or otherwise, except as required by law.
Non-GAAP Financial Measures
Theravance Biopharma provides a non-GAAP profitability target and a non-GAAP metric in this press release. Theravance Biopharma believes that the non-GAAP profitability target and non-GAAP net loss from operations provide meaningful information to assist investors in assessing prospects for future performance and actual performance as they provide better metrics for analyzing the performance of its business by excluding items that may not be indicative of core operating results and the Company's cash position. Because non-GAAP financial targets and metrics, such as non-GAAP profitability and non-GAAP net loss from operations, are not standardized, it may not be possible to compare these measures with other companies' non-GAAP targets or measures having the same or a similar name. Thus, Theravance Biopharma's non-GAAP measures should be considered in addition to, not as a substitute for, or in isolation from, the Company's actual GAAP results and other targets.
Contact:
investor.relations@theravance.com
650-808-4045
| Page 5 of 8 |
| THERAVANCE BIOPHARMA, INC. |
| CONDENSED CONSOLIDATED BALANCE SHEETS |
| (In thousands) |
| June 30, | December 31, | |||||||
| 2023 | 2022 | |||||||
| (Unaudited) | (1) | |||||||
| Assets | ||||||||
| Current assets: | ||||||||
| Cash and cash equivalents and short-term marketable securities | $ | 167,451 | $ | 327,484 | ||||
| Receivables from collaborative arrangements | 15,796 | 16,785 | ||||||
| Prepaid clinical and development services | 979 | 1,513 | ||||||
| Other prepaid and current assets | 7,777 | 7,682 | ||||||
| Total current assets | 192,003 | 353,464 | ||||||
| Long-term marketable securities | - | - | ||||||
| Property and equipment, net | 9,553 | 11,875 | ||||||
| Operating lease assets | 38,453 | 40,126 | ||||||
| Future contingent milestone and royalty assets | 194,200 | 194,200 | ||||||
| Restricted cash | 836 | 836 | ||||||
| Other assets | 11,585 | 6,899 | ||||||
| Total assets | $ | 446,630 | $ | 607,400 | ||||
| Liabilities and Shareholders' Equity | ||||||||
| Current liabilities | $ | 24,546 | $ | 28,715 | ||||
| Long-term operating lease liabilities | 42,521 | 45,407 | ||||||
| Future royalty payment contingency | 26,556 | 25,438 | ||||||
| Unrecognized tax benefits | 64,987 | 64,191 | ||||||
| Other long-term liabilities | 7,859 | 1,849 | ||||||
| Shareholders' equity | 280,161 | 441,800 | ||||||
| Total liabilities and shareholders’ equity | $ | 446,630 | $ | 607,400 | ||||
| (1) | The condensed consolidated balance sheet as of December 31, 2022 has been derived from the audited consolidated financial statements included in the Company's Annual Report on Form 10-K for the year ended December 31, 2022. |
| Page 6 of 8 |
| THERAVANCE BIOPHARMA, INC. |
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
| (In thousands, except per share data) |
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| Revenue: | ||||||||||||||||
| Viatris collaboration agreement (1) | $ | 13,743 | $ | 10,878 | $ | 24,154 | $ | 21,565 | ||||||||
| Collaboration revenue | 6 | 172 | 12 | 181 | ||||||||||||
| Licensing revenue | - | - | - | 2,500 | ||||||||||||
| Total revenue | 13,749 | 11,050 | 24,166 | 24,246 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Research and development (2) | 9,425 | 14,924 | 23,997 | 38,177 | ||||||||||||
| Selling, general and administrative (2) | 19,278 | 16,222 | 38,461 | 34,064 | ||||||||||||
| Restructuring and related expenses (2) | 1,169 | 3,005 | 2,743 | 12,329 | ||||||||||||
| Total costs and expenses | 29,872 | 34,151 | 65,201 | 84,570 | ||||||||||||
| Loss from operations | (16,123 | ) | (23,101 | ) | (41,035 | ) | (60,324 | ) | ||||||||
| Interest expense | (568 | ) | (2,137 | ) | (1,118 | ) | (4,274 | ) | ||||||||
| Interest income and other income (expense), net | 2,504 | 2,440 | 5,483 | 2,065 | ||||||||||||
| Loss from continuing operations before income taxes | (14,187 | ) | (22,798 | ) | (36,670 | ) | (62,533 | ) | ||||||||
| Provision for income tax (expense) benefit | (1,458 | ) | 5 | (1,063 | ) | (519 | ) | |||||||||
| Net loss from continuing operations | (15,645 | ) | (22,793 | ) | (37,733 | ) | (63,052 | ) | ||||||||
| Income from discontinued operations before income taxes | - | 14,602 | - | 28,915 | ||||||||||||
| Provision for income tax expense | - | - | - | - | ||||||||||||
| Net income from discontinued operations | - | 14,602 | - | 28,915 | ||||||||||||
| Net loss | $ | (15,645 | ) | $ | (8,191 | ) | $ | (37,733 | ) | $ | (34,137 | ) | ||||
| Net income (loss) per share: | ||||||||||||||||
| Continuing operations - basic and diluted | $ | (0.28 | ) | $ | (0.30 | ) | $ | (0.63 | ) | $ | (0.83 | ) | ||||
| Discontinued operations - basic and diluted | $ | - | $ | 0.19 | $ | - | $ | 0.38 | ||||||||
| Net income (loss) - basic and diluted | $ | (0.28 | ) | $ | (0.11 | ) | $ | (0.63 | ) | $ | (0.45 | ) | ||||
| Shares used to compute per share calculations - basic and diluted | 56,682 | 76,270 | 59,791 | 75,761 | ||||||||||||
| Non-GAAP net loss from continuing operations | $ | (7,355 | ) | $ | (13,089 | ) | $ | (22,267 | ) | $ | (38,279 | ) | ||||
| (1) | While Viatris, Inc. records the total YUPELRI net sales, the Company is entitled to a 35% share of the net profit (loss) pursuant to a co-promotion agreement with Viatris as presented below: |
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| (In thousands) | 2023 | 2022 | 2023 | 2022 | ||||||||||||
| YUPELRI net sales (100% recorded by Viatris) | $ | 55,038 | $ | 49,077 | $ | 101,993 | $ | 92,743 | ||||||||
| YUPELRI net sales (Theravance Biopharma implied 35%) | 19,263 | 17,177 | 35,697 | 32,460 | ||||||||||||
| (2) | Amounts include share-based compensation expense as follows: |
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| (In thousands) | 2023 | 2022 | 2023 | 2022 | ||||||||||||
| Research and development | $ | 1,855 | $ | 2,909 | $ | 4,296 | $ | 7,439 | ||||||||
| Selling, general and administrative | 4,409 | 5,030 | 8,632 | 10,528 | ||||||||||||
| Restructuring and related expenses | - | 1,770 | 357 | 6,287 | ||||||||||||
| Total share-based compensation expense | $ | 6,264 | $ | 9,709 | $ | 13,285 | $ | 24,254 | ||||||||
| Page 7 of 8 |
| THERAVANCE BIOPHARMA, INC. |
| Reconciliation of GAAP to Non-GAAP Net Loss from Continuing Operations |
| (In thousands) |
| Three Months Ended June 30, | Six Months Ended June 30, | |||||||||||||||
| 2023 | 2022 | 2023 | 2022 | |||||||||||||
| (Unaudited) | (Unaudited) | |||||||||||||||
| GAAP Net Loss from Continuing Operations | $ | (15,645 | ) | $ | (22,793 | ) | $ | (37,733 | ) | $ | (63,052 | ) | ||||
| Adjustments: | ||||||||||||||||
| Share-based compensation expense | 6,264 | 9,709 | 13,285 | 24,254 | ||||||||||||
| Non-cash interest expense | 568 | - | 1,118 | - | ||||||||||||
| Income tax expense (benefit) | 1,458 | (5 | ) | 1,063 | 519 | |||||||||||
| Non-GAAP Net Loss from Continuing Operations | $ | (7,355 | ) | $ | (13,089 | ) | $ | (22,267 | ) | $ | (38,279 | ) | ||||
| Page 8 of 8 |
Exhibit 99.2
THERAVANCE BIOPHARMA ® , THERAVANCE ® , the Cross/Star logo and MEDICINES THAT MAKE A DIFFERENCE ® are registered trademarks of the Theravance Biopharma group of companies (in the U.S. and certain other countries). All third party trademarks used herein are the property of their respective owners. Second Quarter 2023 Financial Results and Business Update August 7 , 2023 © 2023 Theravance Biopharma. All rights reserved.
Forward - Looking Statements This presentation contains certain "forward - looking" statements as that term is defined in the Private Securities Litigation Ref orm Act of 1995 regarding, among other things, statements relating to goals, plans, objectives, expectations and future events. Theravance Biopharma, Inc. (the “Company”) intends such fo rward - looking statements to be covered by the safe harbor provisions for forward - looking statements contained in Section 21E of the Securities Exchange Act of 1934, as amended, an d the Private Securities Litigation Reform Act of 1995. Examples of such statements include statements relating to: the Company’s repurchase of its ordinary shares by way of an open ma rket share repurchase program, the impact of recent headcount reductions in connection with focusing investments in research, the Company’s governance policies and plans, the Co mpa ny’s expectations regarding its allocation of resources and maintenance of expenditures, the Company’s goals, designs, strategies, plans and objectives, future YUPELRI sal es, the ability to provide value to shareholders, the Company’s regulatory strategies and timing of clinical studies, possible safety, efficacy or differentiation of our investiga tio nal therapy, and contingent payments due to the Company from the sale of the Company’s TRELEGY ELLIPTA royalty interests to Royalty Pharma. These statements are based on the current es timates and assumptions of the management of the Company as of the date of this presentation and are subject to risks, uncertainties, changes in circumstances, assumptions an d o ther factors that may cause the actual results of the Company to be materially different from those reflected in the forward - looking statements. Important factors that could cause ac tual results to differ materially from those indicated by such forward - looking statements include, among others, risks related to: whether the milestone thresholds can be achieved, delay s or difficulties in commencing, enrolling or completing clinical studies, the potential that results from clinical or non - clinical studies indicate the Company’s product candidates or product are unsafe, ineffective or not differentiated, risks of decisions from regulatory authorities that are unfavorable to the Company, dependence on third parties to conduct clinical st udi es, delays or failure to achieve and maintain regulatory approvals for product candidates, risks of collaborating with or relying on third parties to discover, develop, manufacture a nd commercialize products, and risks associated with establishing and maintaining sales, marketing and distribution capabilities with appropriate technical expertise and supporti ng infrastructure, ability to retain key personnel, the impact of the Company’s recent restructuring actions on its employees, partners and others, the ability of the Company to protect and t o e nforce its intellectual property rights, volatility and fluctuations in the trading price and volume of the Company’s shares, and general economic and market conditions. Other risks affecting the Company are in the Company’s Form 10 - Q filed with the SEC on May 10, 2023, and other periodic reports filed with the SEC. In addition to the risks described above and in Theravance Biopharma's filings with the SEC, other unknown or unpredictable factors also could affect Theravance Bi opharma’s results. No forward - looking statements can be guaranteed, and actual results may differ materially from such statements. Given these uncertainties, you should not place un due reliance on these forward - looking statements. Theravance Biopharma assumes no obligation to update its forward - looking statements on account of new information, future events or otherwise, except as required by law. Non - GAAP Financial Measures Theravance Biopharma provides a non - GAAP profitability target and a non - GAAP metric in this presentation. Theravance Biopharma b elieves that the non - GAAP profitability target and non - GAAP net loss from operations provide meaningful information to assist investors in assessing prospects for future performan ce and actual performance as they provide better metrics for analyzing the performance of its business by excluding items that may not be indicative of core operating results an d the Company's cash position. Because non - GAAP financial targets and metrics, such as non - GAAP profitability and non - GAAP net loss from operations, are not standardized, it ma y not be possible to compare these measures with other companies' non - GAAP targets or measures having the same or a similar name. Thus, Theravance Biopharma’s non - GAAP measures should be considered in addition to, not as a substitute for, or in isolation from, the company's actual GAAP results and other targets. 2
Introduction and Overview Rick E Winningham Chief Executive Officer Commercial and Development Update Rhonda F. Farnum Senior Vice President, Chief Business Officer Richard A. Graham Senior Vice President, Research and Development Financial Update Aziz Sawaf Senior Vice President, Chief Financial Officer Closing Remarks Rick E Winningham Chief Executive Officer Agenda 3
Strategic Objectives Focused on Value Creation 4 1. Non - GAAP profit is expected to consist of GAAP income before taxes less share - based compensation expense and non - cash interes t expense. See the section titled "Non - GAAP Financial Measures” on Slide 2 for more information. MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension ; PIFR, peak inspiratory flow rate. Financial ‣ Complete expanded $325M Capital Return by end of 2023 ‣ Achieve non - GAAP 1 profitability through continued YUPELRI growth and expense management ‣ Drive Phase 3 CYPRESS trial to completion in MSA patients with symptomatic nOH ‣ Position ampreloxetine for regulatory and commercial success Ampreloxetine ‣ Continue YUPELRI Net Sales growth by executing on targeted strategies to capture sizeable niche market ‣ Capitalize on PIFR - 2 study results, if successful
2023 Progress 5 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a prof it and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). 2 . Non - GAAP profit is expected to consist of GAAP income before taxes less share - based compensation expense and non - cash interest expense. See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. 3. The first milestone payment, of $50.0 million, will be triggered if Royalty Pharma receives $240.0 million or more in roya lty payments from GSK with respect to 2023 TRELEGY global net sales, which we would expect to occur in the event TRELEGY global net sales reach approximately $2.863 billion. PIFR, peak inspiratory flow rate. Financial ‣ Capital Return Program On track for 2023 completion; $80.5M completed Q2, with $61.2M remaining ‣ Remain on track to generate Non - GAAP 2 Profit in 2H’23, subject to YUPELRI growth ‣ $50M potential TRELEGY milestone: $760M Net Sales in Q2’23 (+29% Y/Y); $1.33B YTD 3 ‣ Continuing Phase 3 CYPRESS trial enrollment and site initiations ‣ Received orphan drug designation in Q2‘23 ‣ Build awareness within medical community : Submitted abstracts for 2H’23 medical conferences Ampreloxetine ‣ Total YUPELRI reported net sales reach $55.0M up 12% Y/Y 1 ‣ Robust retail script growth and market share gains ‣ PIFR - 2 enrollment nearing completion; top - line data in late Q4‘23, with disclosure anticipated in Jan‘24
FDA - approved for maintenance treatment of COPD First and only once - daily, LAMA (long - acting muscarinic agent) nebulized maintenance medicine for COPD Co - promotion agreement with VIATRIS TM (35% / 65% Profit Share)
107,790 113,220 137,760 159,720 156,180 K 20 K 40 K 60 K 80 K 100 K 120 K 140 K 160 K 180 K Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 $49.1 $53.4 $55.7 $47.0 $55.0 0 10 20 30 40 50 60 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 YUPELRI ® | Growing Net Sales and Hospital Volume 7 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a profit and loss sharing arrangement (65% to Viatris; 35% to Theravance Biopharma). 2. Final period figures subject to revision upon finalization. Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through 6/30/2023. YUPELRI Hospital Doses Hospital doses sold increased 45% Q2’23 vs. Q2’22 2 Total YUPELRI Net Sales ($M) Net sales increased 12% Q2’23 vs. Q2’22 1 20% rolling 4 - quarter growth through Q2’23 50% rolling 4 - quarter growth through Q2’23 1. In the US, Viatris is leading the commercialization of YUPELRI, and Theravance Biopharma co - promotes the product under a profit and loss sharing a rrangement (65% to Viatris ; 35% to Theravance Biopharma). 2. Source: IQVIA DDD, HDS, VA and Non - Reporting Hospital through 6/30/2023. Preliminary data subject to revision upon receipt of final data.
YUPELRI ® Hospital and Community Share Trends 8 1. Joint VTRS/TBPH Market Research. * Hospital LA - NEB Market Share - IQVIA DDD through 6/30/2023. †Community LA - NEB Market Share includes Retail + DME / Med B FFS through May’23. 6.6% 7.6% 7.6% 8.6% 9.5% 10.7% 11.3% 11.6% 13.3% 12.5% 14.9% 15.2% 0% 5% 10% 15% 20% 25% 30% 35% Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Hospital LA - NEB Market Share* YUPELRI Hospital LA-NEB Market Share Patients continue treatment in the community setting which is inclusive of both the retail and DME channels 17.4% 18.7% 19.7% 21.4% 22.5% 23.2% 24.1% 25.3% 26.4% 27.1% 28.0% 29.0% 0% 5% 10% 15% 20% 25% 30% 35% Q3'20 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q4'22 Q1'23 Q2'23 Community LA - NEB Market Share † YUPELRI Community LA-NEB Market Share Most patients who receive YUPELRI ® in the hospital are discharged with an Rx 1 LA - NEB Market: YUPELRI, BROVANA, LONHALA, PERFOROMIST, arformoterol, formoterol Hospital LA - NEB Market Share Community LA - NEB Market Share
9 Source: Symphony Health METYS Prescription Dashboard through 6/30/2023. 9.7% 6.8% - 2.0% 10.2% 4.9% 4.1% 6.9% 7.8% K 5 K 10 K 15 K 20 K 25 K 30 K 2021-Q2 2021-Q3 2021-Q4 2022-Q1 2022-Q2 2022-Q3 2022-Q4 2023-Q1 2023-Q2 YUPELRI Retail TRx YUPELRI Retail TRx YUPELRI Retail TRx - 6.1% 9.5% 0.1% 11.0% 4.8% 12.0% 23.4% 5.6% K 1 K 2 K 3 K 4 K 5 K 2021-Q2 2021-Q3 2021-Q4 2022-Q1 2022-Q2 2022-Q3 2022-Q4 2023-Q1 2023-Q2 YUPELRI Retail New to Product Rx YUPELRI Retail New to Product Rx YUPELRI Retail New to Product Rx Axis scale differs from TRx view YUPELRI ® Retail Trends TRx and New Patient Starts Continue to Reach New Quarterly Highs Q /Q Growth
10 Substantial Opportunity for Further YUPELRI ® Growth Long - Acting Nebulized Maintenance Patients Patients Using Short - Acting Nebulized Therapy ~200K Current Long - Acting Neb Patients ~200K Patients Inappropriately Using Short - Acting Nebulized Treatments for Maintenance Therapy Current COPD Patients on Nebulized Therapy COPD Patients Who Could Benefit from Nebulized Therapy 1. Addressable patient population quantifies the number of patients within the intended target profile. Sources: Citeline Pharma Custom Intelligence Primary Research April 2023, Symphony Health METYS Prescription Dashboard, SolutionsRx Med B FFS. COPD, chronic obstructive pulmonary disease; PIFR, peak inspiratory flow rate. ~1.5M Patients on Handheld - Only Maintenance Regimens who Remain Symptomatic ~2M Patients for Whom YUPELRI May Be Appropriate ~60K patients estimated to be on YUPELRI currently Addressable Patient Population (U.S.) 1 Suboptimal PIFR Cognitive Impairment Dexterity Challenges
Development YUPELRI PIFR - 2 Top - line results anticipated Q4 ‘23 CYPRESS (ampreloxetine) Last patient enrolled anticipated H2 ‘24
Randomization 1:1 Results YUPELRI SPIRIVA ® via HH* Once - daily treatment: 12 weeks Run - in YUPELRI ® : Phase 4 Randomized, Double - Blind, Parallel - Group Study (PIFR - 2) 12 Phase 4, Randomized, Double - Blind, Parallel˗Group Study in Adults With Severe - to - Very - Severe COPD and Suboptimal Inspiratory Flow Rate. *Dry powder inhaler (Spiriva ® HandiHaler ® ). COPD, chronic obstructive pulmonary disease; FEV 1 , forced expiratory volume in 1 second; PIFR, peak inspiratory flow rate. Endpoints ‣ Primary: Change from baseline in trough FEV 1 ( Day 85) ‣ Key secondary: Trough overall treatment effect on FEV 1 Sample size ‣ N = Up to 488 GOLD 3 and 4 patients ‣ Top - line data in Q4‘23
PIFR - 1 Experience Informed PIFR - 2 Design Chronic Obstr Pulm Dis . 2019; 6(4): 321 – 331. Note: The ns shown are the numbers in the analysis set or subset. Evaluable ns are 90 (Tio) and 89 (Rev) for the ITT analysis an d 70 (Tio) and 70 (Rev) for the subset analysis. FEV1, forced expiratory volume in one second; ITT, intent - to - treat; LS, least squares; PIFR, peak inspiratory flow rate; REV, revefenacin ; SE, standard error; TIO, tiotropium. P = 0.4461 LS Difference (SE) = 17.0 (22.3) LS Mean Change From Baseline (mL) ITT: GOLD 2/3/4 PIFR < 60 L/min P =0.0248 LS Difference (SE) = 49.1 (21.6) GOLD 3/4 40.9 57.9 0 10 20 30 40 50 60 70 80 90 100 Trough FEV1 TIO 18 μ g (n=104) REV 175 μg (n=102) 23.2 72.3 0 10 20 30 40 50 60 70 80 90 100 Trough FEV1 TIO 18 μ g (n=81) REV 175 μg (n=80) 13
Ampreloxetine Investigational once - daily norepinephrine reuptake inhibitor For symptomatic neurogenic orthostatic hypotension (nOH) in multiple system atrophy (MSA) patients
High Probability of Technical Success CYPRESS: Phase 3 randomized withdrawal (RWD) study in patients with MSA 15 Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products Gu ida nce for Industry https://www.fda.gov/media/121320/download MSA, multiple system atrophy; OHSA, Orthostatic Hypotension Symptom Assessment; RWD, randomized withdrawal design. CYPRESS KEYS: ‣ Primary Endpoint: Change in OHSA Composite Score – Reduces Variability vs. Individual Symptom Score – Informed by Study 0170 Result ‣ Optimized D uration of Ope n - Label and RWD Periods ‣ Aligned with FDA Randomization 1:1 Results Ampreloxetine 10 mg Placebo Once - daily treatment: 8 weeks Ampreloxetine 10 mg Open - Label Once - daily treatment: 12 weeks Double - blind RWD n~100 To be enrolled n~60 Completers
Symptoms of nOH in MSA: Significant Unmet Need 16 Reflects Theravance Biopharma's expectations for ampreloxetine based on clinical trial data to date. Ampreloxetine is in development and not approved for any indication. Data on file. 1. UCSD Neurological Institute (25K - 75K, with ~10K new cases per year); NIH National Institute of Neurological Disorders and Str oke (15K - 50K). 2. Delveinsight MSA Market Forecast (2023); Symptoms associated with orthostatic hypotension in pure autonomic failure and multiple systems atrophy, CJ Mathias (1999). 3 . N ORTHERA ® (droxidopa) [package insert]. Deerfield, IL: Lundbeck. 2014. 4. ProAmatine ® (midodrine hydrochloride) [Warning Ref 4052798]. Lexington, MA: Shire. 2017. MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension; OHSA, Orthostatic Hypotension Symptom Assessment. Droxidopa 3 Midodrine 4 Ampreloxetine Indication Dizziness/lightheadedness due to nOH Symptomatic OH Symptomatic nOH associated with MSA Efficacy / Durability Dizziness/lightheadedness only; efficacy not proven beyond 2 weeks Surrogate: systolic blood pressure increase 1 min after standing OHSA composite ; clinically meaningful and durable response >20 weeks Dosing 3x daily, titrated 3x daily Once - daily Safety Black box warning for supine hypertension No signal for supine hypertension ~50K MSA patients in U.S. 1 (considered orphan disease) MSA Prevalence 70% - 90% of MSA patients experience nOH symptoms 2 Prevalence of nOH in MSA Patients 35K – 45K MSA patients with nOH symptoms Addressable Patient Population Unique Treatment Profile Current Treatment Landscape
Ampreloxetine’s Potential for MSA Patients: Highly Differentiated Therapy Delivering Significant Market Expansion 1. NORTHERA ® (droxidopa) [package insert]. Deerfield, IL: Lundbeck. 2014. 2. ProAmatine ® (midodrine hydrochloride) [Warning Ref 4052798]. Lexington, MA: Shire. 2017. 3. Low, AJMC, 2015 . 4. 2022 MAT Rapid Payer Response KOL and High - Volume Prescriber Research. 5. Kymes , Autonomic Neuroscience: Basic and Clinical, 2020. MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension ; OHSA, Orthostatic Hypotension Symptom Assessment . • No approved therapy has demonstrated a durable effect on nOH symptoms 1,2 • In about half of patients with nOH , supine hypertension complicates management 3 • Many MSA patients remain inadequately managed for nOH symptoms, despite available therapies 4 • Long - term adherence remains low, despite genericization of approved treatments 4,5 17 • A chieve market leadership as the only treatment proven to deliver durable nOH symptom improvement in MSA patients as measured by OSHA Composite • Deliver considerable quality of life improvements to patients and caregivers • Improve rates of compliance and persistence within the treated population • Significantly expand the percentage of MSA patients treated for nOH symptoms Competitive Analysis: Ampreloxetine Should:
Financial Update
Second Quarter 2023 Financials 19 1. Amounts include share - based compensation. 2. Non - GAAP net loss from continuing operations consists of GAAP net loss before taxes excluding share - based compensation expens e and non - cash interest expense; see reconciliation on Slide 20 and the section titled "Non - GAAP Financial Measures“ on Slide 2 for more information. ($, in thousands) Revenue: Viatris collaboration agreement $ 13,743 $ 10,878 $ 24,154 $ 21,565 Collaboration revenue 6 172 12 181 Licensing revenue - - - 2,500 Total revenue 13,749 11,050 24,166 24,246 Costs and expenses: Research and development (1) 9,425 14,924 23,997 38,177 Selling, general and administrative (1) 19,278 16,222 38,461 34,064 Restructuring and related expenses (1) 1,169 3,005 2,743 12,329 Total costs and expenses 29,872 34,151 65,201 84,570 Loss from continuing operations (before tax and other income & expense) $ (16,123) $ (23,101) $ (41,035) $ (60,324) Income from discontinued operations (before tax) - 14,602 - 28,915 Share-based compensation expense: Research and development 1,855 2,909 4,296 7,439 Selling, general and administrative 4,409 5,030 8,632 10,528 Restructuring and related expenses - 1,770 357 6,287 Total share-based compensation expense 6,264 9,709 13,285 24,254 Operating expense excl. share-based compensation and one-time expenses: R&D operating expense (excl. share-based comp and restructuring exp.) 7,570 12,015 19,701 30,738 SG&A operating expense (excl. share-based comp and restructuring exp.) 14,869 11,192 29,829 23,536 Total operating expenses excl. share-based compensation and one-time expenses$ 22,439 $ 23,207 $ 49,530 $ 54,274 Non-GAAP net loss from continuing operations (2) $ (7,355) $ (13,089) $ (22,267) $ (38,279) Three Months Ended June 30, 2023 2022 (Unaudited) Six Months Ended June 30, 2023 2022 (Unaudited)
Second Quarter 2023 Financials (Cont’d) 20 See the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. GAAP Net Loss from Continuing Operations $ (15,645) $ (22,793) $ (37,733) $ (63,052) Adjustments: Share-based compensation expense 6,264 9,709 13,285 24,254 Non-cash interest expense 568 - 1,118 - Income tax expense (benefit) 1,458 (5) 1,063 519 Non-GAAP Net Loss from Continuing Operations $ (7,355) $ (13,089) $ (22,267) $ (38,279) (Unaudited) Reconciliation of GAAP to Non-GAAP Net Loss from Continuing Operations (In thousands) Three Months Ended June 30, Six Months Ended June 30, 2023 2022 2023 2022 (Unaudited)
Q2 2023 Financial Highlights Significant Capital Returns from a Position of Strength 21 1. Non - GAAP loss from continuing operations consists of GAAP loss before taxes excluding share - based compensation expense and no n - cash interest expense; see reconciliation on Slide 20 and the section titled "Non - GAAP Financial Measures“ on Slide 2 for more information. 2. Cash, cash equivalents and marketable securities. SBC, Share - Based Compensation. Metric Q2 ‘23 (M) Q2 ’22 (M) Note VIATRIS Collaboration Revenue $13.7 $10.9 SG&A and R&D Expense, ex - SBC & One - time Items $22.4 $23.2 Share - Based Compensation $6.3 $7.9 • Excluding restructuring expenses in Q3’22 Non - GAAP Loss from Continuing Operations 1 ($7.4) ($13.1) • ~($6.2M) in Q2’23, excluding non - cash impairment charge related to sale of lab equipment Cash and Cash Equivalents 2 (as of quarter - end) $167.5 $132.9 • >$80M of share buybacks in Q2’23 Debt (as of quarter - end) $0.0 $624.7 Shares Outstanding (as of quarter - end) 53.7 76.4 • ~7.3M shares repurchased in Q2’23
2023 Financial Guidance Expected to Generate Non - GAAP 1 Profit in 2H 2023 22 1. Non - GAAP profit is expected to consist of GAAP income before taxes less share - based compensation expense and non - cash interes t expense; see the section titled "Non - GAAP Financial Measures" on Slide 2 for more information. • 2023 OPEX Guidance Range: • R&D: $35M - $45M • SG&A: $45M - $55M • Guidance Excludes: • Non - cash share - based compensation • Non - recurring costs: • Incurred $1.6M in Q1’23 associated with headcount reduction, $1.2M in Q2’23 associated with lab equipment sale • No further severance and termination costs expected • Share - Based Compensation: • Expected to decline materially in 2023 vs. 2022 • Q2’23 down 21% Y/Y, excluding restructuring costs, and 35%, including restructuring
x ~$95M: Purchased GSK's equity stake in Theravance (Sep’22) and completed Dutch auction tender offer (Nov’22) x >$80M completed in Q2 2023 $325 Million Capital Return Program On Track to Complete Program by Year - End 23 Complete ($95M) Open Market Share Buybacks Complete ($169M) ~$264M completed overall; ~$61M remaining in capital return programLE0
Q2’23 Net Sales of $760 M |YTD Net Sales of $1.33B 4 Outer - Year Royalties 3 return in 2029: TRELEGY ELLIPTA Milestones and Royalties GSK’s TRELEGY ELLIPTA (FF/UMEC/VI): First and only once - daily single inhaler triple therapy 24 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone. 2. Based on 10 0% of TRELEGY ELLIPTA royalties. 3. 85 % of TRELEGY ELLIPTA royalties return to Theravance Biopharma beginning July 1, ್ 2029 ್ for sales ex - U.S., and January 1, ್ 2031 ್ for sales within the U.S.; U.S. royalties expected to end late 2032; ex - U.S. royalties expected to end mid - 2030s and are country specific. 4. Source: GSK - reported Net Sales in USD. FF, Fluticasone Furoate; UMEC, Umeclidinium; VI, Vilanterol. Mid - Term Value Long - Term Value • Ex - US royalties return Jul. 1, ௗ 2029 • US royalties return after Jan. 1, ௗ 2031 • Paid directly from Roy alty Pharma Up to $250M of Sales - based milestones 1,2 between 2023 – 2026: GSK remains exclusively responsible for commercialization of TRELEGY ELLIPTA
Theravance Biopharma: Positioned for Value Creation MSA, multiple system atrophy; nOH , neurogenic orthostatic hypotension. Ampreloxetine for nOH new era in treating MSA symptoms Substantial opportunity for further growth Potential to offer a unique, first in class treatment benefit Retained future value of TRELEGY in milestones and certain outer year royalties Retained Value Positioned to create value from a foundation of financial strength Three distinct drivers of value over the near, mid, and long - term 25
Rick E Winningham Chairman and Chief Executive Officer Aziz Sawaf, CFA Senior Vice President, Chief Financial Officer Rhonda F. Farnum Senior Vice President, Chief Business Officer Richard A. Graham Senior Vice President, Research and Development Q&A Session
YUPELRI ® ( revefenacin ) inhalation solution YUPELRI ® inhalation solution is indicated for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD) . Important Safety Information (US) YUPELRI is contraindicated in patients with hypersensitivity to revefenacin or any component of this product . YUPELRI should not be initiated in patients during acutely deteriorating or potentially life - threatening episodes of COPD, or for the relief of acute symptoms, i . e . , as rescue therapy for the treatment of acute episodes of bronchospasm . Acute symptoms should be treated with an inhaled short - acting beta 2 - agonist . As with other inhaled medicines, YUPELRI can produce paradoxical bronchospasm that may be life - threatening . If paradoxical bronchospasm occurs following dosing with YUPELRI, it should be treated immediately with an inhaled, short - acting bronchodilator . YUPELRI should be discontinued immediately and alternative therapy should be instituted . YUPELRI should be used with caution in patients with narrow - angle glaucoma . Patients should be instructed to immediately consult their healthcare provider if they develop any signs and symptoms of acute narrow - angle glaucoma, including eye pain or discomfort, blurred vision, visual halos or colored images in association with red eyes from conjunctival congestion and corneal edema . Worsening of urinary retention may occur . Use with caution in patients with prostatic hyperplasia or bladder - neck obstruction and instruct patients to contact a healthcare provider immediately if symptoms occur . Immediate hypersensitivity reactions may occur after administration of YUPELRI . If a reaction occurs, YUPELRI should be stopped at once and alternative treatments considered . The most common adverse reactions occurring in clinical trials at an incidence greater than or equal to 2 % in the YUPELRI group, and higher than placebo, included cough, nasopharyngitis, upper respiratory infection, headache and back pain . Coadministration of anticholinergic medicines or OATP 1 B 1 and OATP 1 B 3 inhibitors with YUPELRI is not recommended . YUPELRI is not recommended in patients with any degree of hepatic impairment . 27 OATP, organic anion transporting polypeptide.
About YUPELRI ® ( revefenacin ) Inhalation Solution YUPELRI ® ( revefenacin ) inhalation solution is a once - daily nebulized LAMA approved for the maintenance treatment of COPD in the US . Market research by Theravance Biopharma indicates approximately 9 % of the treated COPD patients in the US use nebulizers for ongoing maintenance therapy . 1 LAMAs are a cornerstone of maintenance therapy for COPD and YUPELRI ® is positioned as the first once - daily single - agent bronchodilator product for COPD patients who require, or prefer, nebulized therapy . YUPELRI ® ’s stability in both metered dose inhaler and dry powder device formulations suggest that this LAMA could also serve as a foundation for novel handheld combination products . 28 1. TBPH market research (N=160 physicians); refers to US COPD patients. COPD, chronic obstructive pulmonary disease; LAMA, long - acting muscarinic antagonist.
Appendix
Patent Protection Into Late 2030s 30 COPD, Chronic obstructive pulmonary disease ; nOH, neurogenic orthostatic hypotension; PTE, patent term extensions. Compound Invention Granted / Pending Application Estimated Patent Expiry YUPELRI ® / revefenacin Composition of Matter Granted US 2028 (once PTE awarded) Polymorph Granted US 2030 - 2031 Method for the maintenance treatment of COPD patients Granted US 2039 Ampreloxetine Composition of Matter Granted US 2030 (plus PTE of up to 5 years) Method of Treating nOH Granted US 2037
31 Viatris Collaboration Agreement Revenue Theravance Entitled to Share of US profits (65% to Viatris; 35% to Theravance) 1. Any reimbursement from Viatris attributed to the 65% cost - sharing of our R&D expenses is characterized as a reduction of R&D expense. 2. Amount included as a receivable on the balance sheet as “Receivables from collaborative arrangements.” Viatris Collaboration Agreement Revenue Cash amount receivable from Viatris 1,2 Payment of shared Viatris expenses (35%) Reimbursement of shared Theravance expenses (65%) 35% of YUPELRI ® Net Sales Collaboration Revenue, in any given period can fluctuate by the absolute and relative expenses incurred by Viatris and Theravance, in addition to the Net Sales generated in the period
TRELEGY ELLIPTA Theravance Biopharma and Royalty Pharma Deal Summary • Upfront: $1.1B (Received) • Milestones: Up to $250M 32 1. If both milestones are achieved in a given year, Theravance Biopharma will only earn the higher milestone. 2. Based on 100% of TRELEGY ELLIPTA royalties. 3. U.S. royalties expected to end late 2032; ex - U.S. royalties expected to end mid - 2030s and are country specific. Ampreloxetine (Unsecured Royalty) • Outer Year Royalty (“OYR”): 85% of royalties for TRELEGY ELLIPTA return to Theravance Biopharma: – On and after January 1, ௗ 2031 ௗ for U.S. sales 3 – On and after July 1, ௗ 2029 ௗ for ex - U.S. sales 3 • Upfront payment: $25M (Received) • 1st Regulatory approval milestone: $15M – Approval by either FDA or first of the EMA or all four Germany, France, Italy and Spain • Future royalties paid to Royalty Pharma: – 2.5% on annual global net sales up to $500M – 4.5% on annual global net sales > $500M
Offering Hope to MSA Patients with Symptomatic nOH 33 MSA, multiple system atrophy; nOH, neurogenic orthostatic hypotension. 33rd International Symposium on the Autonomic Nervous System November 2 – 5, 2022: Sheraton Maui , Hawaii Kaufmann H, et al. Abstract 33 / Virtual Poster 117 Blood pressure and pharmacodynamic response of ampreloxetine, a norepinephrine reuptake inhibitor, in patients with symptomatic nOH Biaggioni I, et al. Abstract 34 / Virtual Poster 106 A phase 3, 22 - week, multi - center, randomized withdrawal study of ampreloxetine in treating symptomatic nOH Freeman R, et al. Abstract 30 / Virtual Poster 4 Longitudinal analysis of ampreloxetine for the treatment of symptomatic nOH in subset of patients with MSA Platform Presentations, Session 1, November 2, 2022
Shift Toward Broad Symptomatic Improvement for MSA Patients 1. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170. 2. Biaggioni I, et al. Abstract 34 / Virtual Poster 106; Kaufmann H, et al. Abstract 33 / Virtual Poster 117; Freeman R, et al. Abstract 30 / Virtual Poster 4. MSA, Multiple System Atrophy; nOH, neurogenic orthostatic hypotension; OHDAS, orthostatic hypotension daily activity scale; OHQ, orthostatic hypotension questionnaire; OHSA, Orthostatic Hypotension Symptom Assessment ; PAF, Pure Autonomic Failure; PD, Parkinson’s Disease. “Old” Ampreloxetine Program “New” MSA - focused Ampreloxetine Program MSA PAF MSA PD “Dizziness” based indication for short - term effectiveness Constellation of symptoms - based indication In study 0170, ampreloxetine prevented blood pressure drop and symptoms worsening in MSA 1 Support from the scientific and medical community with 3 scientific presentations presented at the American Autonomic Society meeting 2 Aligned with FDA on new Phase 3 study for approval with OHSA composite as primary endpoint Durable effectiveness 34
‣ Sold TRELEGY ELLIPTA royalty interests for $1.1B upfront , while retaining value through milestones and certain outer - year royalties ‣ Eliminated all debt, ~$650 million ‣ Completed financial restructuring ‣ Initiated $250 million capital return program , of which ~62% was completed as of February 27, 2023 ‣ In study 0170, prevented blood pressure drop and symptoms worsening in MSA 2 ‣ Aligned with FDA on new Phase 3 study for NDA filing with OHSA composite score as primary endpoint ‣ Three scientific platform presentations at American Autonomic Society meeting 3 ‣ Secured up to $40 million from Royalty Pharma for funding ampreloxetine development; $25M to fund majority of new P3 study ‣ Three consecutive quarters of all - time ್ high Net Sales and Profit in Q2 - Q4 ‣ Continued community market share growth every quarter since launch ‣ 53% Y/Y growth in hospital volume , a key driver of overall brand performance 1 ‣ Initiated PIFR - 2 study 2022: A Year of Transformation 35 1. Year - to - date through Q4’22; 2. Data from MSA patients at week 6 of the randomized withdrawal period of study 0170; 3. Biaggioni I, et al. Abstract 34 / Virtual Poster 106; Kaufmann H, et al. Abstract 33 / Virtual Poster 1 17; Freeman R, et al. Abstract 30 / Virtual Poster 4. MSA, multiple system atrophy; OHSA, orthostatic hypotension symptom assessment; PIFR, peak inspiratory flow rate. Financial Ampreloxetine